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Study of Effectiveness of Telemedicine in Identifying Diabetic Retinopathy Cases (DRTM)

21. april 2015 opdateret af: Sanil Joseph, Aravind Eye Care System

Effectiveness of Tele-medicine in Identifying Diabetic Retinopathy Cases Attending Diabetologists' Clinics Compared to the Conventional Referral System

The aim of this study is to compare the effectiveness of identifying diabetic retinopathy using tele-medicine based Digital Retinal Imaging in Diabetes Clinics with that of the conventional referral system.

Hypothesis: Tele-medicine based digital retinal imaging involving a diabetes centre will identify proportionately more diabetic patients with DR and lead to higher acceptance rate with subsequent ophthalmic referral and management

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

The design is a cluster randomized trial of tele-medicine versus usual care in diabetic patients. The primary outcome of the study is the proportion of patients with confirmed DR at Aravind Eye Hospital (AEH). DR will be graded using the International Clinical Diabetic Retinopathy Disease Severity Scale. A sample size of 616 patients in both arms is required to detect a risk ratio of 1.8 or above at 90% power, 1% alpha and a design effect of 2. Eight clinics will be recruited and equally randomized to tele-medicine or usual care stratified by distance from AEH. Inclusion criteria include a confirmed diagnosis of diabetes, age over 50, no retinal exam in the previous year. In the tele-medicine arm patients will be offered fundus imaging and patients diagnosed with DR or probable DR will be counselled to visit AEH to confirm DR. In the usual care arm, the eligible patients will be counselled and referred to undergo an eye examination at AEH. In both the arms the counselling and the awareness creation materials will be standardized. Fundus imaging will be offered at the end of the study to those who refuse initially and all those in the usual arm who did not attend AEH.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

801

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Indien
    • Tamil Nadu
      • Madurai, Tamil Nadu, Indien, 625020
        • Aravind Eye Hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

50 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Diabetic patients (as per ICD-9 code 250) in the age group of ≥50 years

Exclusion Criteria:

  • Patients <50 years of age
  • Already enrolled as study patients at the diabetes centre
  • Patients screened for DR in free camps organized by the diabetes centre
  • Diabetic patients who underwent retinal examination in the previous year prior to this intervention
  • Patients with disability (physical or mental) who have difficulty in travelling to the eye hospital

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Sundhedstjenesteforskning
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Tele-medicine
Tele-medicine aided retinal imaging and referral to eye hospital
Andet: Tele-medicine
Patients at the diabetes clinics will be subjected to non-mydriatic retinal imaging and the images will be transferred to the eye hospital via internet using a specified software - Aravind Diabetic Retinopathy Evaluation Software (ADRES) that enables a retinal specialist to read and grad the image and send the feedback immediately to the diabetes clinic. Based on the presence or absence of DR the patients will be referred to the eye hospital for detailed retinal examination.
Andre navne:
  • Tele-medicine aided retinal imaging
Andet: Conventional Referral
Patients will be counselled on the importance of eye examination and will be referred to the eye hospital in the conventional manner.
Andet: Conventional referral
All eligible patients in the conventional arm will be counselled on the importance of eye screening and will be referred to the eye hospital

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Proportion of patients with confirmed Diabetic Retinopathy (DR) diagnosed at the eye hospital
Tidsramme: 6 months
Out of the patients referred from the diabetes clinics to the eye hospital, the number of patients with confirmed DR will be measured. This proportion will be compared between the two arms.
6 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
The severity of diabetic retinopathy (DR)
Tidsramme: 6 months
Among patients confirmed with DR, the severity of the disease will be measured using standard classification (Diabetic Retinopathy Disease Severity Scale) approved by the American Academy of Ophthalmology
6 months
The acceptance rate for referral in each arm
Tidsramme: 6 months
Out of the patients referred from the diabetes clinic, the number of patients actually reported to the eye hospital will be measured.
6 months
Proportion of patients eligible for referral who had DR and who did not attend
Tidsramme: 6 months
Patients who are referred by not attended to the eye hospital will be followed up and examined to find out what proportion of them actually as DR
6 months

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Barriers to compliance
Tidsramme: 6 months
Patients will be interviewed to identify the barriers to compliance following the referral
6 months
Drivers of acceptance
Tidsramme: 6 months
Patients will be interviewed to identify the factors that encouraged them to visit the eye hospital following referral
6 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Aravind Eye Care System

Samarbejdspartnere

London School of Hygiene and Tropical Medicine

Efterforskere

  • Ledende efterforsker: Sanil Joseph, MHA, MSc, Lions Aravind Institute of Community Ophthalmology, Aravind Eye Hospital, Madurai, India
  • Studiestol: Ramasamy Kim, DO, DNB, Aravind Eye Hospital, Madruai, India
  • Studiestol: Thulasiraj Ravilla, MBA, Lions Aravind Institute of Community Ophthalmology, Aravind Eye Hospital, Madurai
  • Studiestol: Astrid Fletcher, MSc, PhD, London School of Hygiene and Tropical Medicine

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. maj 2014

Primær færdiggørelse (Faktiske)

1. januar 2015

Studieafslutning (Faktiske)

1. marts 2015

Datoer for studieregistrering

Først indsendt

5. februar 2014

Først indsendt, der opfyldte QC-kriterier

8. marts 2014

Først opslået (Skøn)

13. marts 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

22. april 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

21. april 2015

Sidst verificeret

1. april 2015

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • WT097685MA

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Diabetisk retinopati

Kliniske forsøg med Tele-medicine

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